Devicemaker giant Medtronic has agreed to a $2.4 million settlement in a case at Massachusetts’ Suffolk Superior Court over claims about deceptively marketing its Infuse Bone Graft.
The payment amount may just be pocket change for the largest global medical device company, which has historically focused on products for the diabetic population. Yet Attorney General Maura Healey said it led to the conclusion of a multistate investigation, alongside attorneys general from Oregon, California, Illinois and Washington state, totaling a $12 million settlement.
The complaint claimed that Medtronic “used deceptive company-sponsored scientific literature to convey false and misleading claims about Infuse’s safety, comparative efficacy, and superiority in order to expand the market” for the device, including offering millions in consulting fees to physician authors who published studies that “omitted discussion of adverse results, downplayed side-effects,” among other allegedly deceptive information.
As part of the settlement, Medtronic also agreed to imposed requirements to have Infuse-related clinical trial data made available on ClinicalTrials.gov.
The Ireland-based company received FDA approval for Infuse in 2002, which is intended to help stimulate bone growth, for lumbar spine procedures. — Ana Mulero